What changed between the draft committee report and the plenary report

Removed:Data on substances in products (mixtures and articles in terms of REACH) are covered by the term “chemicals data” as proposed in Article 2(10), and so are data on alternatives to targeted substances. However, such data are scattered across different regulatory procedures, including from different legislations (e.g. RoHS, REACH). The proposal does not provide for the structured access to these important items, thereby not allowing targeted retrieval of relevant and actionable information, across legislations and procedures (e.g. all products linked with a specific substance, alternatives discussed in relation to a specific substance or use).

Removed:Article 13 – paragraph 3: 3. Where researchers or research consortia funded by Union framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.

Removed:This amendment to the legal act aims at keeping the focus on chemicals as per the Platform's objective.

Removed:Article 14 – paragraph 5 a (new): 5a. This paragraph shall not apply to the Union acts listed in Annex II.

Removed:According to the Staff Working Document accompanying the Proposal, this may gradually be imposed on applicants – increasing administrative burden. IUCLID isn’t suitable for human and animal medicines and therefore for the EMA. This requirement would therefore increase administrative burden on both industry and EMA. It should not apply to the Union acts listed in Annex II.

Removed:Article 14 – paragraph 6: 6. The Commission and the Agencies shall cooperate when setting standard formats to ensure coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches. They shall also consult stakeholders.

Removed:Standard data formats and controlled vocabularies must be developed in consultation with stakeholders and especially the industry, as in the longer term, the formats and vocabularies set by the Agencies will also be used for the submission of data by the duty holders under the individual pieces of legislation.

Removed:Article 14 – paragraph 7: 7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between data formats that could cause interoperability problems. Stakeholders shall be consulted to ensure duty holders contribute to ensure optimal operability. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.

Removed:Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Removed:Article 15 – paragraph 5 – point a: (a) make them available free of charge through the common data platform in a way that supports their re-use;

Removed:The amendment aims at clarifying that these vocabularies should be freely available and open for re-use. Open data does not necessarily mean data free of IPR restrictions.

Removed:Article 15 – paragraph 6: 6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and shall consult stakeholders.

Removed:Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Removed:Article 15 – paragraph 7: 7. The Commission and the Agencies shall take the necessary and appropriate measures to monitor and identify at an early stage any potential divergence between controlled vocabularies. Stakeholders shall be consulted to ensure duty holders contribute to ensure optimal operability. If a divergence is identified, the Agencies concerned shall cooperate to resolve it or, where the divergence is justified, explain the underlying reasons. Where the Agencies concerned are not able to resolve that divergence, they shall draw up a joint report and present it to the Commission. The report shall clearly outline the reasons for the divergence, clarify any underlying technical issue and make a proposal to remedy the divergence.

Removed:Stakeholders should be consulted, because, in the longer term, the formats and vocabularies set by the Agencies will be used also for the submission of data by the duty holders under the individual pieces of legislation, therefore affecting different interested parties.

Removed:Article 15 – paragraph 8: 8. The Commission shall adopt an implementing decision to remedy the divergence in cases where it is not justified.

Removed:There might be decisions where divergences will be justified.

Article 16 – paragraph 1: 1. The Authorities shall have access to all the chemicals data contained in the common data platform, including data which is marked as confidential under Article 5(2), second sentence.

Change 9

Removed:This provision aims at providing further legal clarity and predictability.

Added:Article 16 – paragraph 2: 2. The Authorities shall take the necessary measures, including security measures, to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2), is not made available to the public.

Change 10

Changed:Article 16 – paragraph 2:3: 2.3. The Authoritiespublic shall take the necessary measures, including securityhave measures,access to ensureall thatthe informationchemicals data contained in the common data platform marked as confidential in accordance with Article 5(2),except isdata notwhich madeare availablemarked to the public in accordance with the provisions onbe confidentialityconfidential under the originating UnionArticle act.5(2).

Change 11

Removed:Whilst the proposal includes provisions protecting the confidentiality of some data shared, they need to be strengthened to ensure that the protection of confidential data granted under each corresponding EU act is not undermined by this proposal. Furthermore, in case of conflict between the provisions on confidentiality of this proposal and those laid in corresponding EU acts, the latter should prevail.

Added:Article 17 – paragraph 1: 1. The Authorities may use the chemicals data contained in the common data platform or in the Database of Study Notifications in the performance of any of their activities, where those activities support the development, implementation or enforcement of legislation and policy.

Removed:Article 16 – paragraph 3: 3. The general public shall only have access to the chemicals data contained in the common data platform considered as available to the public in accordance with the originating Union act.

Added:Article 17 – paragraph 2: 2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, and to the possibility of identifying data gaps in the applications received from business operators, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.

Removed:The use of the defined term 'originating Union act' aims to better clarify the relevant reference.

Added:Article 17 – paragraph 3 a (new): 3a. The common data platform shall also include terms and conditions, particularly regarding the respect of intellectual property rights and other related rights.

Removed:Article 17 – paragraph 1: 1. The Authorities may use the chemicals data contained in the common data platform in the performance of any of their activities, where those activities support the development, implementation or enforcement of legislation and policy, in full transparency and in accordance with the consultation procedures stipulated in the relevant legislation.

Added:Article 18 – paragraph 1: 1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission, shall, in consultation with Member States, establish, operate, maintain and update as appropriate a framework of indicators to monitor chemical pollution throughout the chemical’s lifecycle, including emissions, occurrence and fate, to monitor the drivers and impacts of exposure to chemicals, and to measure the effectiveness of chemicals legislation and the transition towards the production of safe and sustainable chemicals.

Removed:Lack of enforcement is a concerning topic for the public. Hence, given the role of enforcement with a view to improving citizens’ trust, the common data platform should provide structured access to the enforcement activities at the European and national levels and their outcomes. In addition, greater visibility of enforcement activities would facilitate consistency in the enforcement approaches of Member States and promote a level playing field on the internal market. While the term “chemicals data” as proposed in Article 2(10) is rather inclusive, comprising both scientific facts and e.g. regulatory process-related information, it is not clear if this covers enforcement/compliance data. Therefore, it should be clarified that this type of information is included. In addition, when the authorities intend to re-use the data for the secondary purposes (Article 17), it should be conducted in an open and transparent manner and in accordance with the consultation procedure stipulated in the relevant legislation. Each study is performed under the specific requirements and objectives of the concerned legislation. The validity and extent of the reuse of study outcomes for other purposes than the original objective needs to be carefully considered by taking the substance identity and limitation of applicability of each study into account.

Added:Article 18 – paragraph 1 a (new): 1a. The framework of indicators referred to in paragraph 1 shall include an aggregated territory-based risk indicator at different administrative levels as defined in Regulation (EC) No 1059/2003 to monitor time and spatial trends in exposure of populations to individual and multiple chemicals and health risks associated with such exposure and co-exposure.

Change 12

Changed:Article 1718 – paragraph 32: a2. (new):The 3a.framework Unlessof otherwiseindicators specifiedreferred to in theparagraph Union1, actsand listedthe inaggregated Annexindicator I,referred theto datain sharingparagraph and1a, datashall protectionbe rulesaccessible in Articlethe 25form of Regulation (EC) Noan 1907/2006indicator shalldashboard, applywhich tothe anyEEA studyshall summariesestablish orand robustwhich summariesthe ofECHA studiesshall mademake available through the common data platform.

Change 13

Removed:Data protection aspects are not explicitly included in the proposed Regulation but are vital to protect investments in new data by economic actors. The amendment seeks to align requirements in this Regulation with standard practices for data protection enshrined in the REACH Regulation.

Added:Article 19 – paragraph 2 – subparagraph 1 – point b: (b) national early warning systems;

Removed:Article 17 – paragraph 3 b (new): 3b. It shall be clearly mentioned on the common data platform, in particular for the attention of the general public, that the data may be owned by third parties and that any use of the data without prior approval from the data owner might infringe their rights. The common data platform shall also include terms and conditions, particularly regarding intellectual property rights and other related rights.

Added:Article 19 – paragraph 2 – subparagraph 1 – point c: (c) data that the EEA holds, including data from human biomonitoring as referred to in Article 6, and data from the framework of indicators and the aggregated indicator as referred to in Article 18;

Removed:This provision aims at ensuring that the general public understands that some data may be protected by intellectual property rights.

Added:Article 19 – paragraph 2 – subparagraph 1 – point e a (new): (ea) relevant datasets from the EU Datasets Catalogue established by Article 57 of Regulation (EU) …/… of the European Parliament and of the Council on the European Health Data Space ... [OP: please add number and publication reference];

Removed:Article 18 – paragraph 1 a (new): 1a. Stakeholders shall be consulted to help avoid unnecessary duplication of studies, within the EEA or beyond.

Added:Article 19 – paragraph 2 – subparagraph 1 – point e b (new): (eb) relevant information resulting from national enforcement programmes;

Removed:The Framework of Indicators (Article 18) should involve the stakeholder consultation in the process. Before new scientific studies are undertaken, it is important that all relevant information is taken into consideration, including on the methodologies of the study and to avoid potential duplication of work.

Added:Article 19 – paragraph 2 – subparagraph 1 – point e c (new): (ec) relevant data or information submitted by researchers.

Change 14

Changed:Article 19 – paragraph 3: 3. The ECHA, the EFSA, the EU-OSHA and the EMA shall identify and gather relevant available data obtained through theon early warning signals systemobtained establishedpursuant byto this Regulation or from the field falling within their mandate and provide this data to the EEA. The EEA shall develop guidance for identification of emerging chemicals risks in cooperation with ECHA, the EFSA, the EU-OSHA and the EMA and other relevant parties.

Change 15

Removed:The EEA should develop guidance for identification of emerging chemicals risks in cooperation with all relevant parties, based on current ECHA stakeholder practices. To ensure sufficient time for such a guidance document to be developed, there is a need to reconsider the timeline currently proposed in Article 19(4).

Added:Article 19 – paragraph 4: 4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall be prepared by ... [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals. Within six months of the presentation of the report, the Authorities shall undertake regulatory, policy or enforcement actions accordingly or provide justification if they decide not to proceed with any action related to any of the early warning signals identified by the report, including an assessment of the possible consequences of non-action.

Removed:Article 19 – paragraph 5: 5. The EEA shall make data on early warning signals that it holds or hosts and that led to a positive identification of an emerging risk as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform. Data that did not lead to a positive identification of an emerging risk as described in Article 19, paragraph 2, shall not be included in the common data platform.

Added:Article 19 – paragraph 4 a (new): 4a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.

Removed:This provision aims at ensuring that data is assessed or complemented with scientific evidence before being listed publicly in the Common Data Platform on Chemicals as early warnings to avoid confusion among the users.

Added:Article 19 – paragraph 5: 5. The EEA shall make all data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform.

Removed:Article 21 – paragraph 1: 1. Using the best resources available, the ECHA may commission scientific studies to support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy.

Added:Article 19 – paragraph 5 a (new): 5a. The Commission shall take into account, where relevant, the emerging chemical risks identified, in accordance with this Article, in the strategic planning of R&I activities of Regulation (EU) 2021/6951a. / 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013.

Removed:Article 21 – paragraph 2: 2. The Commission may request the ECHA to commission the scientific studies referred to in paragraph 1 and Article 20(4), point (b), of this Regulation.

Added:Article 20 – paragraph 1: 1. The ECHA shall establish, operate and maintain an observatory for specific chemicals or groups of chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on the chemicals’ properties, safety aspects, uses and market presence.

Removed:This amendment provides a better clarification.

Added:Article 20 – paragraph 2: 2. By ... [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of an implementing act. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means.

Removed:Article 21 – paragraph 3: 3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall not commission studies with a predominant research objective. Stakeholders shall be consulted in order to avoid unnecessary duplication of studies.

Added:Article 20 – paragraph 4 – point c: (c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate the identification of potential further research needs or risk management measures, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.

Removed:The Data Generation Mechanism (Article 21) should involve the stakeholder consultation in the process. Before new scientific studies are undertaken, it is important that all relevant information is taken into consideration, including on the methodologies of the study and to avoid potential duplication of work.

Added:Article 21 – paragraph 1: 1. Using the best independent resources available, the ECHA may commission scientific studies to: / (a) support the implementation of Union acts on chemicals or groups of chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy; / (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation; / (c) conduct a Union-wide data sampling survey of human biomonitoring in collaboration with Member States.

Removed:Article 22 – paragraph 1: 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, within three months of the date of the commissioning, information referred to in paragraph 2 related to studies on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, under the Union acts listed in Annex I and where handling or holding of data is under the responsibility of EFSA and ECHA. / However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 / (a) in case of studies that are to be notified under Article 32b of Regulation (EC) No 178/2002; / (b) when a valid justification for late or non-notification is provided by business operators. / The assessment of the validity of justifications for non-notifications shall be done by ECHA / (c) in case of studies under Articles 40, 41 and 46 of Regulation (EC) No 1907/2006 (REACH). They shall be excluded from the notification requirement, given that such studies are carried out in response to a request from the authority.